FDA Grants Fast Track Designation for Heart Failure Developmental Treatment

By Adam Hochron
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The FDA has granted fast track designation for omecamtiv mecarbil for the treatment of chronic heart failure with reduced ejection fraction. 

Omecamtiv mecarbil is described in a press release from the manufacturer as a “novel selective cardiac myosin activator, also known as a cardiac myotrope.” 

David M. Reese, MD, executive vice president of research and development, noted that “half of heart failure patients will die within five years of diagnosis, underscoring the urgent need for new therapies for this grievous condition.”  

Preclinical data for the treatment has shown it “increases cardiac contractility without increasing intracellular myocyte calcium concentrations or myocardial oxygen consumption,” according to the release. 

Omecamtiv mecarbil is currently being tested in the GALACTIC-HF phase 3 clinical trials to evaluate its effectiveness compared to placebo. The trials include more than 8,000 patients in 35 countries who had either been hospitalized at the time they enrolled in the trial or had been hospitalized or admitted to an emergency room for heart failure within a year of screening. 

Top-line results from the trials are expected in the fourth quarter of 2020. 

“We are pleased that the FDA has granted Fast Track designation for omecamtiv mecarbil for the potential treatment of heart failure," Robert I. Blum, president and chief executive officer of Cytokinetics, said in the press release. "The prevalence of heart failure is growing with our aging demographics, and GALACTIC-HF is designed to assess the clinical effects of our novel myosin activator in patients meaningfully at risk.”


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